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Recruiting

NCT Number: NCT07268118

Pain Control for Cervical Ripening Balloon

No standard of care exists for pain management during cervical ripening balloon placement. The purpose of this study is to evaluate if vaginal topical lidocaine reduces pain related to cervical ripening balloon placement during induction of labor.

Recruiting

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Key information

Conditions

Labor Induction

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Sarah Little, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Gestational age ≥37 weeks
  • Viable pregnancy
  • Intact membranes
  • English speaking
  • Interested in cervical ripening balloon placement
  • Able to provide consent

Exclusion criteria

  • Allergy or sensitivity to lidocaine
  • Patients that already have neuraxial anesthesia (i.e. spinal, epidural, combined spinal/epidural)
  • Known uterine or cervical anomalies

Treatment and study plan

topical vaginal application lidocaine gel

Drug

Application of topical vaginal lidocaine prior to cervical balloon ripening

Primary outcomes

  1. Patient-reported pain during cervical ripening balloon placement.

    Time frame: Within 24 hours of cervical balloon ripening

    Patient-reported pain score during cervical ripening balloon placement on a visual analog scale from 0 (no pain) to 10 (most pain).

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Little, MD

CONTACT

[email protected]

6176677000

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

Randomized Control Trial for Pain Control With Topical Lidocaine for Cervical Ripening Balloon Placement

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 5, 2025
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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